Medical device package validation incorporates package performance testing, accelerated aging and sterile integrity testing following the guidelines of ISO 11607.
To get a medical device to market, a medical device manufacturer must follow the guidelines laid out in ISO 11607-1 and -2. Whether your company has a predetermined protocol, or you need one written, Westpak is here to help. Depending on your needs, we can assist in protocol development or provide a company specific document with a detailed test plan. Consult our experienced staff when you need answers about testing.
Environmental Conditioning is a process of subjecting a test specimen to various temperature and humidity conditions in order to determine the effect of these conditions on the test specimen. Conducting conditioning in a chamber allows for tight controls over the inputs.
Many materials from which containers and packages are made, especially cellulosic materials, undergo changes in physical properties as the temperature and the relative humidity (RH) to which they are exposed are varied. Most plastic components change strength in direct proportion to changes in temperature.
ISTA Series (all)
MIL STD 810G
(65) Temperature and Humidity Chambers
(1) Thermal Shock Chamber
(4) Temperature and Altitude Chambers
Distribution Testing is the practice of conducting tests that simulate the distribution environment in a laboratory. Laboratory testing provides a controlled and repeatable setting whereby the ability of products and shipping units to withstand the distribution environment can be determined.
The Distribution requirements for the Life Sciences and BioTech industries are unique; the package containing the medical product or device must be able to protect and maintain sterility of the products contained within. Westpak accomplishes this by subjecting test samples to a variety of tests such as impact, compression, vibration and altitude. Prescribed by ISO 11607, these tests replicate the distribution environment encountered in various distribution cycles.
Types of Distribution Testing
Impact – This test evaluates the ability of a package to handle and protect the product against collisions that occur in the distribution environment. Whether the package is dropped, knocked or simply banged around, the impact can cause product damage. To conduct an impact test, the package is allowed to free-fall onto corners, edges, and flat surfaces. Many test procedures conduct all of the impacts from the same drop height regardless of orientation.
Compression – Compression testing is conducted for a variety of different reasons, most of which involve determining the top load capability of materials or systems, primarily packages. The goal of the test is to determine the maximum safe load that the packages or other system components can withstand. Compression testing is a key element in determining package and product design verification and quality control.
Vibration – This refers to the ability to replicate the vehicle excitation that occurs in the real world to your packaged product in order to witness the effects and identify weaknesses. Vibration occurs in all forms of transportation and at varying levels of intensity and complexity in the real world. The cushioning of a package system also has a natural frequency. If the natural frequency of the product and the package coincide, damage is likely to occur. Most so-called “hidden damage” during transit is likely caused by compound resonance.
Altitude – This simulates the reduced air pressure experienced at higher elevations and the impact on the integrity of the sealed package. Sealed flexible systems have the potential to fail when exposed to altitude. In fact, altitude exposure by truck transport can exceed the levels experienced in commercial air transportation. Additional packaging costs may be incurred to pull a partial or full vacuum on the packaging in order to avoid the effects of altitude.
Loose-Load – Also called “Bounce Testing” and “Fixed Displacement Vibration,” this test was conceived in the early days of package testing in an attempt to duplicate the negative effects of vehicle vibration, primarily over the truck road. To conduct the test, the package under test is placed on the platform. The speed of rotation of the drive is increased slowly until the package momentarily leaves the surface of the platform. This speed is maintained for the duration of the test which is typically 15 to 60 minutes.
Peel/Tensile Testing is the process used to measure the force to pull apart two bonded surfaces. It is often used in the medical device industry to measure and quantify the strength of seals on medical pouched products as well as other sealed flexible packages.
The Burst Test internally pressurizes a package until the package "bursts" open in response to pressurization. This allows the test to have a higher probability of detecting the weakest area of the seal and provide a measurement of the pressure required to "burst" open the package.
Burst Testing is often used in the medical device industry to gauge and quantify the strength of the medical device package Sterile Barrier System (SBS). It is also used for other sealed flexible packages across many different industries. This test is useful for measuring the ability of a Sterile Barrier System to withstand rapid internal pressurization by yielding an ultimate failure pressure throughout the process. The burst strength peak value recorded is useful in determining if challenges or aging time have reduced package strength. By placing the package within restraining plates during pressurization, the dimensional stability of the package is maintained in a manner that results in stresses applied more uniformly along the perimeter of the package seals.
(3) – Burst Test Systems
Gross Leak Detection / Bubble Test
Gross Leak Detection / Bubble Test
This test is conducted by submerging a lightly pressurized package under water to visually inspect for streams of bubbles that identify a leak or defect in both porous and non-porous packaging systems.
Gross Leak Detection, or Bubble testing, is a widely used qualitative method of determining defects or gross leaks in sterile medical device packaging. This is the most common method used to determine the ability of a package to maintain a sterile barrier since it tests the entire Sterile Barrier System and not only the seal.
Primary packages or Sterile Barrier Systems are subjected to this test to determine if their ability to maintain a sterile barrier has been compromised by tears, holes, or improper seals. Properly applied in a package validation test plan (within guidelines of ISO 11607) this method has significant advantages to methods such as microbial challenge when determining if a Sterile Barrier System has been compromised.
(8) Gross Leak Detection tanks with state-of-the-art controls
Dye Penetration Testing
Dye Penetration Testing
Dye Penetration Testing is an effective and widely used method of locating defects in pouch and tray seals. The test process places enough dye penetration solution into a package to create a 5mm deep well of dye along the seal’s inner edge. Defects and leaks in the seal area are observed by the test operator.
Detecting leaks and defects in a Sterile Barrier System or primary package of a terminally sterilized medical device package can be challenging. When properly applied (within the guidelines of ISO 11607) leaks observed indicate a defect greater than 50 microns and would fail the criteria for a sterile barrier. This test is also useful as a second opinion or verification to leaks observed during Gross Leak Detection testing. Folds can often create a concentration of bubbles which may have been falsely determined as a failure.
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Accelerated Aging - oftentimes referred to as Accelerated Shelf Life Testing - is commonly used in the medical device industry to accelerate the effects of time on a Sterile Barrier System to establish Shelf Life parameters. The Accelerated Aging process is based on the relationship of temperature and material reaction rate.
Properly applied in a package validation test plan (and within ISO 11607 guidelines), Accelerated Aging can result in a decreased time to market for a new product. For example, per the Arrhenius equation, a Sterile Barrier System that is subjected to 40 days of Accelerated Aging at +55° Celsius has similar aging characteristics as a 1-year-old Real Time sample. Accelerated Aging data is recognized by regulatory bodies as an acceptable means to generate data quickly, however this data is only accepted until those tests can be correlated to samples from “Real Time” conditions.
Real Time Aging
Real Time Aging
Real Time Aging - oftentimes referred to as Shelf Life Testing - is exactly what the name implies. This testing is conducted at ambient conditions in actual real time in order to analyze the conditions of packages and/or products and the effects that time has on them. Real Time Aging studies can be performed to confirm the results of Accelerated Aging on test samples.
While it might seem easy enough to keep some samples in your office for a few years, it is highly recommended to submit those samples to an accredited laboratory for a Real Time Aging study. At the conclusion, you’ll have all your original samples present and accounted for, plus a credible test report based on data from calibrated instrumentation.
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